The development of new generic versions of expensive biologic drugs "faces a long, tough road to realization" because the complex generics "will likely face tough regulatory scrutiny, as well as high development and marketing costs," the Wall Street Journal reports.
According to the Journal, President Obama's legislative agenda is expected to include a proposal to allow generic versions of biologic drugs, also known as "biosimilars."
One challenge for biosimilars is that they would be approved for the same use as the brand-name drug on which they are based but would not automatically be substituted for the brand name drug. Because biologics are so complex, their manufacturing makes them sensitive to small changes that could alter their structure or how they work in the body. Therefore, the biosimilar would be given its own brand name, forcing generic companies to market their version of the drug to physicians.
Biosimilars also face another issue in that they are different than typical drugs. During the approval process for typical, small-molecule generics, the developer must show they have the same active ingredient and action as the brand-name version. That allows typical generic drugs to use the brand-name drugs' original testing and avoid paying for new trials. However, biosimilars complexity forces manufacturers of them to conduct more trials to ensure their safety.
According to the Journal, "The cost of the marketing, and clinical trials to get approval, would make the industry drastically different than that for small-molecule drugs." In addition, many biotech drugs will not lose their patent protection for a number of years, making it impossible to develop biosimilars.
According to the Journal, the "multiple barriers" for biosimilars likely would limit the number of companies capable of producing them. The high cost of developing generic biotech drugs could mean that the larger, brand-name companies -- which "have the necessary cash, the relevant marketing experience and already possess needed technological capabilities" -- may end up making them, the Journal reports (Gryta, Wall Street Journal, 3/4).